JP7428552B2 - guide wire - Google Patents

Description

TECHNICAL FIELD The present invention relates to guidewires.

2. Description of the Related Art Guide wires are known that are used when inserting medical devices such as catheters into blood vessels. In addition to having flexibility and restorability against bending, such guidewires also have improved sliding properties against combined devices such as catheters and endoscopes, and improved safety by making the guidewires less likely to break. is desired. For example, Patent Document 1 discloses that in a guide wire, a step space between the proximal end of the resin coating layer and the wire main body is filled on the proximal end side of the resin coating layer that covers the outer periphery of the distal end of the wire main body. It is described that the device includes an annular member provided therein. For example, Patent Document 2 discloses that a guidewire includes a first polymer layer disposed between a core member and a helical coil, and a second polymer layer disposed around an outer surface of the first polymer layer. It is stated that you should prepare.

Patent No. 5526218 Special Publication No. 2003-513764

However, in the guide wire described in Patent Document 1, since the area of the contact surface between the resin coating layer and the annular member is small, when shear stress is applied along the longitudinal direction of the guide wire, the resin at this contact surface There was a possibility that the coating layer and the annular member would separate. Furthermore, in the guide wire described in Patent Document 2, the entire helical coil from the distal end to the proximal end is covered with the first polymer layer and the second polymer layer, so there is a problem of poor flexibility against bending. there were. These issues are not limited to the vascular system, but also the guidewires inserted into various organs within the human body, such as the lymphatic system, biliary tract system, urinary tract system, respiratory tract system, digestive system, secretory glands, and reproductive organs. common to

The present invention has been made to solve at least part of the above-mentioned problems, and an object of the present invention is to provide a guidewire that is flexible, difficult to break, and has improved safety.

The present invention has been made to solve at least part of the above-mentioned problems, and can be realized as the following forms.

(1) According to one embodiment of the present invention, a guidewire is provided. This guide wire includes a core wire, a first resin layer that covers a part of the core wire, another part of the core wire, a coil body wound around the outside of the first resin layer, and a first resin layer that covers a part of the core wire. a second resin layer covering a coil body, a part of the coil body being embedded in the first resin layer and the second resin layer.

According to this configuration, the guide wire has a configuration in which a portion of the coil body is embedded in the first resin layer and the second resin layer. That is, the guide wire has a portion where the first resin layer and the second resin layer are bonded via the coil body (hereinafter also referred to as an "indirectly bonded portion") at the contact surfaces where the first resin layer and the second resin layer are in contact with the coil body. , the first resin layer and the second resin layer have a portion (hereinafter also referred to as a “directly bonded portion”) in which the first resin layer and the second resin layer are directly bonded at the contact surfaces of the first and second resin layers. Therefore, compared to a configuration that only has a direct bonding portion, the area of the bonding portion (in other words, the contact surface between the members that contribute to bonding the first resin layer and the second resin layer) is reduced. The bonding strength between the first resin layer and the second resin layer can be improved. Furthermore, since the first resin layer and the second resin layer have an indirect joint portion where the first resin layer and the second resin layer are joined via the coil body, even if shear stress is applied along the longitudinal direction of the guide wire, , the first resin layer and the second resin layer are difficult to separate. Furthermore, since only a portion of the coil body is buried in the first resin layer and the second resin layer, the entire coil body from the tip to the base end is buried in the resin layer. Flexibility against bending can be imparted compared to the above. As a result, according to the guide wire of this embodiment, it is possible to provide a guide wire that has flexibility, is difficult to break, and has improved safety.

(2) In the guide wire of the above embodiment, the second resin layer may have a lower hardness than the first resin layer.
According to this configuration, since the second resin layer has lower hardness than the first resin layer, the second resin layer and the coil body covered with the second resin layer can be configured flexibly. , the flexibility of the guide wire can be further improved. Moreover, since the hardness of the first resin layer is greater than or equal to the hardness of the second resin layer, the first resin layer functions as a protective member that protects a part of the coil body and a part of the core wire. be able to.

(3) In the guide wire of the above embodiment, the proximal end of the first resin layer is located closer to the proximal side of the core wire than the proximal end of the second resin layer. You can leave it there.
According to this configuration, the proximal end of the first resin layer is located closer to the proximal end of the core wire than the proximal end of the second resin layer. Therefore, the first resin layer can function as a protection member that protects the proximal end of the coil body and a portion of the core wire corresponding to the proximal end of the coil body.

(4) In the guide wire of the above embodiment, the proximal end of the first resin layer may be thinner toward the proximal end of the core wire.
According to this configuration, the thickness of the proximal end of the first resin layer becomes thinner toward the proximal end of the core wire, which prevents it from being caught on a combined device such as a catheter or an endoscope. It is possible to improve the slidability with respect to the device used in combination.

(5) In the guide wire of the above embodiment, the first resin layer has an inner envelope portion on the proximal end side in which the entire proximal end portion of the coil body is embedded in the first resin layer, and The second resin layer may be disposed only on the distal end side of the inner packaging portion.
According to this configuration, the first resin layer has, on the proximal end side, an inner envelope portion in which the entire proximal end portion of the coil body is embedded in the first resin layer. Therefore, by making the hardness of the first resin layer higher than the hardness of the second resin layer, the proximal end of the coil body and the part of the core wire corresponding to the proximal end of the coil body can be separated. You can improve your protection ability. In addition, processing is facilitated when the thickness of the proximal end of the first resin layer is gradually reduced toward the proximal end.

(6) In the guide wire of the above embodiment, the core wire may have a protrusion with an enlarged diameter at a position in contact with the proximal end of the first resin layer.
According to this configuration, the core wire has a protrusion with an enlarged diameter at a position in contact with the proximal end of the first resin layer. Therefore, the protrusion of the core wire can protect the proximal end of the first resin layer, and prevent the proximal end of the first resin layer from peeling off. Further, the movement of the wire (the wire forming the coil body) when shear stress is applied to the guide wire in the longitudinal direction can be restricted by the protrusion of the core wire. As a result, it is possible to provide a guide wire that is more difficult to break and has improved safety.

(7) In the guide wire of the above embodiment, the protrusion has a reduced diameter portion whose outer diameter decreases from the proximal end to the distal end, and the proximal end of the first resin layer may be provided in contact with the reduced diameter portion.
According to this configuration, the proximal end of the first resin layer is provided in contact with the reduced diameter portion of the protrusion. Therefore, the proximal end of the first resin layer can be reliably protected, and stress concentration when shear stress is applied to the guide wire in the longitudinal direction can be suppressed. It is possible to reduce the possibility that kinks will occur in the core wire. Further, since the occurrence of a step caused by the core wire being exposed on the tip side of the protrusion is suppressed, it is possible to suppress the wire from being caught on the combined device, and to improve the slidability with respect to the combined device.

(8) In the guide wire of the above embodiment, a regulation further provided between the coil body and the core wire on the distal side side of the first resin layer, and in which another part of the coil body is embedded. It may also include a section.
According to this configuration, the guide wire further includes a regulating portion provided between the coil body and the core wire on the distal side of the first resin layer, and in which another part of the coil body is embedded. Therefore, by regulating the movement of the strands (the strands that make up the coil body) when shear stress is applied to the guide wire in the longitudinal direction, the movement of the strands (the strands that make up the coil body) is restricted by the regulating section, making it more difficult to break and safer. A guide wire with improved properties can be provided.

Note that the present invention can be realized in various forms, such as a guide wire, a coil body covered with a plurality of resin layers, a method for manufacturing a guide wire, a method for manufacturing a coil body, etc. can do.

FIG. 2 is an explanatory diagram illustrating the configuration of a guide wire according to the first embodiment. FIG. 2 is an enlarged view of a portion of the guidewire (FIG. 1). FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a second embodiment. It is an explanatory view showing a part of the proximal end side of the guide wire of a 2nd embodiment. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a third embodiment. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a fourth embodiment. FIG. 7 is an enlarged view of the vicinity of a protrusion of a guide wire according to a fourth embodiment. FIG. 7 is an enlarged view of the vicinity of a protrusion of a guide wire in a comparative example. FIG. 7 is an enlarged view of the vicinity of a protrusion of a guide wire in a comparative example. FIG. 7 is an enlarged view of the vicinity of a protrusion of a guide wire in a comparative example. FIG. 7 is an enlarged view of the vicinity of a protrusion of a guide wire in a comparative example. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a fifth embodiment. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a sixth embodiment. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to a seventh embodiment. FIG. 7 is an explanatory diagram illustrating the configuration of a guide wire according to an eighth embodiment.

<First embodiment>
FIG. 1 is an explanatory diagram illustrating the configuration of a guide wire 1 according to the first embodiment. The guide wire 1 is a medical device inserted into a living body lumen in each organ of the human body, such as the vascular system, lymph gland system, biliary tract system, urinary tract system, respiratory tract system, digestive system, secretory glands, and reproductive organs. . The guide wire 1 may be inserted directly into the living body lumen mentioned above, or may be inserted into the living body lumen via an endoscope. The guide wire 1 includes a core wire 10 , a coil body 20 , a second resin layer 30 , a distal end joint portion 40 , a first resin layer 50 , and an intermediate fixing portion 60 .

In FIG. 1, an axis passing through the center of the guide wire 1 is represented by an axis O (dotted chain line). In the example of FIG. 1, the axis O coincides with an axis passing through the guidewire 1 and the centers of each component. However, the axis O may be different from the central axes of the guidewire 1 and each component. FIG. 1 shows mutually orthogonal XYZ axes. The X axis corresponds to the longitudinal direction (axis O direction) of the guide wire 1, the Y axis corresponds to the height direction of the guide wire 1, and the Z axis corresponds to the width direction of the guide wire 1. The left side (-X-axis direction) of FIG. 1 is called the "distal side" of the guidewire 1 and each component, and the right side (+X-axis direction) of FIG. 1 is called the "proximal side" of the guidewire 1 and each component. call. Regarding the guide wire 1 and each component, the end located on the distal side is called the "tip", and the tip and the vicinity thereof are called the "tip". Further, the end located on the proximal side is referred to as the "proximal end", and the proximal end and its vicinity are referred to as the "proximal end". The distal end is inserted into the living body, and the proximal end is operated by an operator such as a doctor. These points are also common in FIG. 1 and subsequent figures.

The core wire 10 is a tapered elongated member having a larger diameter on the base end side and a smaller diameter on the distal end side. The core wire 10 has, in order from the distal end to the proximal end, a small diameter portion 11, a first reduced diameter portion 12, a first large diameter portion 13, a second reduced diameter portion 14, and a second large diameter portion 15. are doing. The outer diameter and length of each part of the core wire 10 can be arbitrarily determined.

The narrow diameter portion 11 is formed at the tip of the core wire 10. The narrow diameter portion 11 is a portion of the core wire 10 having the smallest outer diameter, and has a substantially cylindrical shape with a substantially constant outer diameter. A tip joint portion 40 is formed at the tip of the narrow diameter portion 11 . The first reduced diameter portion 12 is formed between the small diameter portion 11 and the first large diameter portion 13. The first reduced diameter portion 12 has a tapered shape with an outer diameter reduced from the proximal end toward the distal end. The first large diameter portion 13 is formed between the first reduced diameter portion 12 and the second reduced diameter portion 14 . The first large diameter portion 13 has a substantially cylindrical shape having a substantially constant outer diameter larger than the outer diameter of the small diameter portion 11 . A portion of the base end side of the first large diameter portion 13 is covered with a first resin layer 50 . Further, the outer circumferential surfaces of the small diameter portion 11 , the first reduced diameter portion 12 , and the first large diameter portion 13 are covered with the coil body 20 .

The second reduced diameter portion 14 is formed between the first large diameter portion 13 and the second large diameter portion 15. The second reduced diameter portion 14 has a tapered shape with an outer diameter reduced from the proximal end toward the distal end. The second large diameter portion 15 is formed at the base end portion of the core wire 10 . The second large diameter portion 15 is the portion of the core wire 10 having the largest outer diameter, and has a substantially cylindrical shape with a substantially constant outer diameter. The second reduced diameter portion 14 and the second large diameter portion 15 are not covered by the coil body 20 and are used when the operator grasps the guide wire 1. The outer diameter and length of each part (small diameter part 11 to second large diameter part 15) of the core wire 10 can be arbitrarily determined.

The coil body 20 is formed by winding a wire 21 in a helical shape around the core wire 10 and the first resin layer 50. The coil body 20 has a substantially cylindrical shape having a substantially constant outer diameter from the proximal end to the distal end. The coil body 20 is arranged so as to cover the small diameter portion 11, the first reduced diameter portion 12, and the first large diameter portion 13 of the core wire 10 with a space provided therebetween on the distal end side. Further, the coil body 20 is disposed so as to cover the outside of the first resin layer 50 in a state where the coil body 20 bites into the outside (outer peripheral surface) of the first resin layer 50 on the base end side. Note that the coil body 20 is not arranged in the second reduced diameter part 14 and the second large diameter part 15 of the core wire 10.

The coil body 20 of this embodiment is formed by winding one strand 21 into a single thread, and is a loosely wound single thread coil in which a gap is formed between adjacent strands 21. The coil body 20 may be a multi-filament coil formed by winding a plurality of wires 21 into multiple threads, or may be a multi-filament coil formed by winding a plurality of wires 21 into a single thread. It may be a single stranded wire coil formed by using a plurality of stranded wires made by twisting a plurality of strands 21 together, and a multi-stranded wire coil formed by winding each stranded wire into multiple threads. There may be. The outer diameter and inner diameter of the coil body 20 can be arbitrarily determined.

The coil body 20 is fixed to the core wire 10 by a distal end joint part 40 and an intermediate fixing part 60. The distal end joint portion 40 is a member that joins the distal end portion of the coil body 20 and the distal end portion of the narrow diameter portion 11 of the core wire 10. The intermediate fixing portion 60 is a member that fixes a portion of the coil body 20 and a portion of the first large diameter portion 13 of the core wire 10 in the vicinity of the intermediate portion of the coil body 20 in the axis O direction. Note that the guide wire 1 may be formed with a plurality of intermediate fixing parts for fixing the coil body 20 and the core wire 10.

The first resin layer 50 is a resin layer that covers the outside (outer peripheral surface) of a portion of the core wire 10 . Specifically, the first resin layer 50 covers a portion of the base end side of the first large diameter portion 13 of the core wire 10 . The first resin layer 50 can be formed of a resin material that is harder than the second resin layer 30, such as hard urethane. Here, "hardness" refers to micro Vickers hardness measured by a micro Vickers hardness tester.

The first resin layer 50 has a recessed portion 51 and a thin portion 52 . The biting portion 51 is a portion in which the wire 21 of the coil body 20 is embedded on the outside (outer peripheral surface), and has a substantially constant outer diameter except for the recess in which the wire 21 is embedded. In the illustrated cross section, approximately half of the wire 21 is buried in the biting portion 51. However, the proportion of the strands 21 buried in the biting portion 51 may be changed arbitrarily. The thin portion 52 is an end portion on the proximal side of the first resin layer 50, in other words, a portion provided on the proximal side of the biting portion 51, and the thickness of the resin layer varies from the distal side to the proximal end. This is a part that gradually becomes thinner toward the sides. In this embodiment, the length L1 of the biting portion 51 in the axis O direction is longer than the length L2 of the thin portion 52 in the axis O direction. The lengths L1 and L2 can be arbitrarily determined.

The second resin layer 30 is a resin layer that covers the outside (outer peripheral surface) of the coil body 20. Specifically, the second resin layer 30 covers the entire outer side of the coil body 20 from the tip to the base end, the tip joint portion 40, and the biting portion 51 of the first resin layer 50. The outside of the thin portion 52 of the first resin layer 50 is not covered. The second resin layer 30 can be formed of a resin material with lower hardness than the first resin layer 50, for example, soft urethane.

A depressed portion 31 is formed in a portion of the second resin layer 30 that covers the coil body 20 and does not cover the first resin layer 50 . The depressed portion 31 is a portion where the resin layer enters the gap between the adjacent strands 21 . By having the depressed portion 31, the contact area between the second resin layer 30 and the coil body 20 (specifically, the strands 21) can be increased, and the bonding between the second resin layer 30 and the coil body 20 can be increased. Strength can be improved. Note that the second resin layer 30 does not need to have the depressed portion 31. In addition, in the portion of the second resin layer 30 that covers both the coil body 20 and the first resin layer 50, the second resin layer 30 and the first resin layer layer 50 is in contact.

With such a configuration, in the guide wire 1 of this embodiment, a part of the coil body 20 (specifically, a part of the proximal end side of the coil body 20) is connected to the second resin layer 30 and the second resin layer 30. It has a configuration in which it is embedded in the resin layer 50 of No. 1. In the guide wire 1, the proximal end 50p of the first resin layer 50 is located closer to the proximal side than the proximal end 30p of the second resin layer 30.

The core wire 10 preferably has antithrombotic properties, flexibility, and biocompatibility, and is made of, for example, a stainless steel alloy (SUS304, SUS316, etc.), a superelastic alloy such as a nickel-titanium alloy, a piano wire, a nickel-chromium alloy, It can be formed from materials such as cobalt alloy and tungsten. The strands 21 of the coil body 20 are made of stainless steel alloys such as SUS304 and SUS316, superelastic alloys such as nickel titanium alloys, piano wires, radiolucent alloys such as nickel-chromium alloys, cobalt alloys, gold, platinum, tungsten, It can be formed of a radiopaque alloy such as an alloy containing these elements (eg, platinum-nickel alloy). The tip joint portion 40 is preferably flexible and can be formed of a resin material such as polyurethane or polyurethane elastomer. The intermediate fixing portion 60 can be formed of any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn--Ag alloy, Au--Sn alloy, or adhesive such as epoxy adhesive. Note that the materials of each member described above are merely examples, and may be formed of known materials other than those mentioned above.

The guide wire 1 can be produced, for example, as follows. First, the first resin layer 50 is formed on a portion of the first large diameter portion 13 of the core wire 10 . Next, an arbitrary bonding agent such as an epoxy adhesive is applied to the outside (outer peripheral surface) of the biting portion 51 of the first resin layer 50. Next, the coil body 20 is formed by winding the strands 21 around the outside of the small diameter portion 11 to the first large diameter portion 13 of the core wire 10 and the biting portion 51 of the first resin layer 50. Next, the tip joint portion 40 and the intermediate fixing portion 60 are formed. Next, an arbitrary bonding agent such as an epoxy adhesive is applied to the outside (outer peripheral surface) of the coil body 20, the tip joint portion 40, and the recessed portion 51 of the first resin layer 50. Next, the second resin layer 30 is formed on the outside (outer peripheral surface) of the coil body 20, the tip joint portion 40, and the recessed portion 51 of the first resin layer 50. Finally, crimping is performed from the outside of the second resin layer 30 to bring the second resin layer 30 into close contact with the coil body 20, the tip joint 40, and the first resin layer 50. Note that the caulking process may be omitted.

FIG. 2 is an enlarged view of a portion pa of the guidewire 1 (FIG. 1). As described above, the guide wire 1 has a configuration in which a portion of the coil body 20 is embedded in the first resin layer 50 and the second resin layer 30 (FIG. 1: length L1 portion). . That is, as shown in FIG. 2, in the guide wire 1, the first resin layer 50 and the second resin layer 30 are connected via the coil body 20 at the contact surfaces where the first resin layer 50 and the second resin layer 30 respectively contact the coil body 20. A portion P1 (hereinafter also referred to as an "indirectly bonded portion") is a portion where the first resin layer 50 and the second resin layer 30 are directly bonded at the contact surfaces of the first and second resin layers 50 and 30. P2 (hereinafter also referred to as "direct binding part"). Furthermore, in the method for manufacturing the guide wire 1 described above, the second resin layer 30 is crimped from the outside. Therefore, in the guide wire 1, the first resin layer 50 and the second resin layer 30 have a chemical bonding force (bonding force due to the bonding agent) at the indirect bonding portion P1 and a chemical bonding force at the direct bonding portion P2. They are bonded by force (bonding force due to the bonding agent) and mechanical bonding force at the portions P3 facing each other via the coil body 20.

As described above, since the guide wire 1 of the first embodiment has the indirect joint portion P1 and the direct joint portion P2, the joint portion ( In other words, the area of the contact surface between the members that contributes to the bonding between the first resin layer 50 and the second resin layer 30 can be increased. 30 can be improved. Furthermore, by having the indirect joint portion P1 where the first resin layer 50 and the second resin layer 30 are joined via the coil body 20, the guide wire 1 can be Even if a shear stress SS along the line is applied, the first resin layer 50 and the second resin layer 30 are difficult to separate. Furthermore, since only a portion of the coil body 20 is buried in the first resin layer 50 and the second resin layer 30 (FIG. 1: length L1 portion), the distance from the tip of the coil body 20 to the base is Flexibility against bending can be imparted compared to a structure in which the entire structure up to the ends is embedded in the resin layer. As a result, according to the guide wire 1 of this embodiment, it is possible to provide a guide wire 1 that has flexibility, is difficult to break, and has improved safety. Note that in this embodiment, "damage" is used as a general term for a part of a guide wire component to peel off, a member to separate from each other, and a certain member to break.

Further, in the guide wire 1 of the first embodiment, since the second resin layer 30 has a lower hardness than the first resin layer 50, the second resin layer 30 and the coil covered with the second resin layer 30 The body 20 can be configured flexibly, and the flexibility of the guide wire 1 can be further improved. Further, since the hardness of the first resin layer 50 is higher than that of the second resin layer 30, the first resin layer 50 protects a part of the coil body 20 and a part of the core wire 10. It can function as a protection member.

Furthermore, in the guide wire 1 of the first embodiment, the proximal end 50p of the first resin layer 50 is closer to the proximal end of the core wire 10 than the proximal end 30p of the second resin layer 30. It is located on the side (Figure 1). Therefore, the first resin layer 50 can function as a protection member that protects the proximal end of the coil body 20 and a portion of the core wire 10 corresponding to the proximal end of the coil body 20. . Further, since the first resin layer 50 has the thin portion 52 , the thickness of the first resin layer 50 becomes thinner as the proximal end of the first resin layer 50 approaches the proximal end of the core wire 10 . For this reason, it is possible to suppress catching on a combined device such as a catheter or an endoscope, and improve slidability with respect to the combined device.

<Second embodiment>
FIG. 3 is an explanatory diagram illustrating the configuration of a guide wire 1A according to the second embodiment. The guide wire 1A of the second embodiment further includes a regulating section 70 in addition to the configuration described in the first embodiment. The regulating portion 70 is provided between the coil body 20 and the core wire 10 (first large diameter portion 13) on the distal end side of the first resin layer 50. The strands 21 of the coil body 20 are buried on the outside (outer peripheral surface) of the regulating portion 70 . The regulating portion 70 has a substantially constant outer diameter except for the recessed portion in which the wire 21 is embedded. In this embodiment, the length L3 of the regulating portion 70 in the direction of the axis O is shorter than the length L1 of the biting portion 51 of the first resin layer 50 and longer than the length L2 of the thin portion 52. The regulating portion 70 can be formed of any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn--Ag alloy, Au--Sn alloy, or adhesive such as epoxy adhesive.

In this way, the configuration of the guide wire 1A can be changed in various ways, and may include the restriction section 70. In the illustrated example, the proximal surface of the regulating portion 70 is in contact with the distal end surface of the first resin layer 50, but the regulating portion 70 is provided apart from the first resin layer 50. It's okay to be hit. Further, the length L3 provided with the regulating portion 70 can be arbitrarily determined, and the magnitude relationship with the lengths L1 and L2 can also be arbitrarily changed. The guide wire 1A of the second embodiment can also provide the same effects as the first embodiment.

FIG. 4 is an explanatory diagram showing a portion of the proximal end side of the guide wire 1A of the second embodiment. The guide wire 1A of the second embodiment is provided between the coil body 20 and the core wire 10 on the distal side of the first resin layer 50, and the other part of the coil body 20 (FIG. 3: length L3 A regulating part 70 is provided in which a part) is embedded. Therefore, when shear stress SS is applied to the guide wire 1A in the longitudinal direction (X-axis direction), the movement of the wire 21 (the wire 21 constituting the coil body 20) is controlled by the regulating portion 70. By regulating the range of movement of the wire 21, it is possible to keep the range of movement of the wire 21 within the range AM closer to the proximal end than the regulation part 70. As a result, it is possible to provide a guide wire 1A that is more difficult to break and has improved safety.

<Third embodiment>
FIG. 5 is an explanatory diagram illustrating the configuration of a guide wire 1B according to the third embodiment. The guide wire 1B of the third embodiment has the configuration described in the second embodiment, but includes a first resin layer 50B instead of the first resin layer 50, and a second resin layer 50B instead of the second resin layer 30. A resin layer 30B is provided.

The first resin layer 50B has an internal envelope portion 53 on the proximal side of the biting portion 51 and on the distal side of the thin wall portion 52 (in other words, between the biting portion 51 and the thin wall portion 52). have. All of the base end portion of the coil body 20, in other words, all of the strands 21 forming the coil body 20 at the base end of the coil body 20 are buried in the inner packaging portion 53. The inner envelope portion 53 has a substantially constant outer diameter, and the outer diameter of the inner envelope portion 53 is approximately the same as the portion of the second resin layer 30B having the largest outer diameter. In the illustrated example, the length L13 of the inner packaging portion 53 in the direction of the axis O is approximately the same as the length L11 of the biting portion 51. The second resin layer 30B is not provided on the outside (outer peripheral surface) of the inner package 53, and the outside of the inner package 53 is exposed to the outside. That is, the second resin layer 30B is disposed only on the distal end side of the inner envelope portion 53.

In this way, the configuration of the guide wire 1B can be modified in various ways, and the first resin layer 50B may have an inner envelope part 53 in which the entire proximal end of the coil body 20 is embedded. In the illustrated example, the thin part 52 in which the thickness of the resin layer gradually becomes thinner is provided on the base end side of the inner envelope part 53 having a substantially constant outer diameter, but the inner envelope part 53 and the thin part 52 are integrated. It may be configured as follows. In other words, the resin layer may have a structure in which the thickness of the resin layer in the inner packaging portion 53 gradually becomes thinner. Further, the outside (outer peripheral surface) of the inner packaging portion 53 may be covered with the second resin layer 30B. The guide wire 1B of the third embodiment can also provide the same effects as those of the first and second embodiments.

Further, according to the guide wire 1B of the third embodiment, the first resin layer 50B has an inner envelope portion 53 on the proximal end side in which the entire proximal end portion of the coil body 20 is embedded in the first resin layer 50B. have. Therefore, by making the hardness of the first resin layer 50B higher than the hardness of the second resin layer 30B, it is possible to correspond to the proximal end of the coil body 20 and the proximal end of the coil body 20. The protection ability for protecting a part of the core wire 10 can be improved. Furthermore, processing is facilitated when the thickness of the resin layer at the proximal end of the first resin layer 50B is gradually reduced toward the proximal end.

<Fourth embodiment>
FIG. 6 is an explanatory diagram illustrating the configuration of a guide wire 1C according to the fourth embodiment. FIG. 7 is an enlarged view of the vicinity of the protrusion 16 of the guide wire 1C of the fourth embodiment. The guide wire 1C of the fourth embodiment has the configuration described in the third embodiment, but includes a core wire 10C instead of the core wire 10, and a first resin layer 50C instead of the first resin layer 50B.

The core wire 10C further includes a protrusion 16 in addition to the small diameter portion 11 to the second large diameter portion 15 described in the first embodiment. The protruding portion 16 is provided near the proximal end of the first large diameter portion 13 at a position in contact with the proximal end 50p of the first resin layer 50C. As shown in FIG. 7, the outer diameter Φ2 of the protrusion 16 at the portion where the outer diameter of the protrusion 16 is the largest is larger than the outer diameter Φ1 of the first large diameter portion 13, and It is smaller than the outer diameter Φ3 of the inner envelope part 53. As shown in FIG. 7, the protrusion 16 has a reduced diameter part 161 whose outer diameter decreases from Φ2 to Φ1 from the proximal end to the distal end, and a reduced diameter part 161 whose outer diameter decreases from the proximal end to the distal end. It has an enlarged diameter portion 162 whose diameter increases from Φ1 to Φ2. The first resin layer 50C includes a thin portion 52C instead of the thin portion 52 in the configuration described in the third embodiment. The end portion 50p on the proximal side of the thin portion 52C is located on the reduced diameter portion 161 of the projection portion 16. That is, the proximal end 50p of the first resin layer 50C is provided in contact with the reduced diameter portion 161 of the protrusion 16.

In this way, the configuration of the guide wire 1C can be modified in various ways, and includes a core wire 10C having a protrusion 16, and the proximal end 50p of the first resin layer 50C is protected by the protrusion 16. configuration may be adopted. The outer diameter Φ2 of the protrusion 16 can be arbitrarily changed as long as it is larger than the outer diameter Φ1 of the first large diameter part 13 and smaller than the outer diameter Φ3 of the inner envelope part 53. The guide wire 1C of the fourth embodiment can also provide the same effects as those of the first to third embodiments.

Further, according to the guide wire 1C of the fourth embodiment, the core wire 10C has a protrusion 16 with an enlarged diameter at a position in contact with the proximal end 50p of the first resin layer 50C. Therefore, the proximal end 50p of the first resin layer 50C can be protected by the protrusion 16 of the core wire 10C, and peeling of the proximal end 50p of the first resin layer 50C can be suppressed. In addition, the movement of the wire 21 (the wire 21 constituting the coil body 20) when shear stress is applied to the guide wire 1C in the longitudinal direction (X-axis direction) is measured at the protrusion of the core wire 10C. 16. As a result, it is possible to provide a guide wire 1C that is more difficult to break and has improved safety.

Furthermore, according to the guide wire 1C of the fourth embodiment, the proximal end portion 50p of the first resin layer 50C is provided in contact with the reduced diameter portion 161 of the projection portion 16. Therefore, it is possible to reliably protect the proximal end 50p of the first resin layer 50C, and when shear stress is applied to the guide wire 1C in the longitudinal direction (X-axis direction). In addition, stress concentration on the protrusion 16 can be suppressed to reduce the possibility that a kink will occur in the core wire 10C. In addition, since the occurrence of a step due to the core wire 10C being exposed on the distal side of the protrusion 16 is suppressed, it is possible to suppress the wire from being caught on the combined device, and to improve the slidability with respect to the combined device.

<Comparative example>
FIG. 8 is an enlarged view of the vicinity of the protrusion 16w of the guide wire 1w of the comparative example. The guide wire 1w of the comparative example has a protrusion 16w in place of the protrusion 16 and a thin part 52w in place of the thin part 52C in the configuration of the fourth embodiment. The protruding portion 16w does not have the reduced diameter portion 161 described in the fourth embodiment, and the base end portion 50p of the thin portion 52w of the first resin layer 50C is the portion where the outer diameter of the protruding portion 16w is the largest. It is located in In the guide wire 1w of such a comparative example, when shear stress is applied to the guide wire 1w along the longitudinal direction (X-axis direction), stress concentrates on the corner EP of the protrusion 16w, There is a possibility that a kink may occur in the core wire 10C. Therefore, as described in the fourth embodiment, it is preferable that the proximal end portion 50p of the first resin layer 50C be provided in contact with the reduced diameter portion 161 of the projection portion 16.

FIG. 9 is an enlarged view of the vicinity of the protrusion 16 of the guide wire 1x of the comparative example. The guide wire 1x of the comparative example includes a first resin layer 50x instead of the first resin layer 50 in the configuration of the fourth embodiment. The end portion 50p on the proximal side of the first resin layer 50x (in other words, the end portion 50p on the proximal side of the thin portion 52 of the first resin layer 50x) is disposed in the first large diameter portion 13. Therefore, it is not provided in contact with the reduced diameter portion 161 of the protrusion 16 . In the guide wire 1x of such a comparative example, since the first large diameter portion 13 is exposed on the distal end side of the protrusion 16, there is a possibility that the protrusion 16 may be caught on the combined device. In other words, in the guide wire 1x of the comparative example, there is room for improvement in slidability with respect to the combined device. Therefore, as described in the fourth embodiment, it is preferable that the proximal end portion 50p of the first resin layer 50C be provided in contact with the reduced diameter portion 161 of the projection portion 16.

FIG. 10 is an enlarged view of the vicinity of the protrusion 16 of the guide wire 1y of the comparative example. The guide wire 1y of the comparative example includes a first resin layer 50y instead of the first resin layer 50 in the configuration of the fourth embodiment. The proximal end 50p of the first resin layer 50y (in other words, the proximal end 50p of the thin portion 52 of the first resin layer 50x) is in contact with the enlarged diameter portion 162 of the protrusion 16. It is provided. In the guide wire 1y of such a comparative example, the proximal end 50p of the first resin layer 50y cannot be protected by the protrusion 16, and peeling occurs at the proximal end 50p of the first resin layer 50y. There is a risk that this may occur. Therefore, as described in the fourth embodiment, it is preferable that the proximal end portion 50p of the first resin layer 50C be provided in contact with the reduced diameter portion 161 of the projection portion 16.

FIG. 11 is an enlarged view of the vicinity of the protrusion 16z of the guide wire 1z of the comparative example. The guide wire 1z of the comparative example includes a protrusion 16z in place of the protrusion 16 in the configuration of the fourth embodiment. The outer diameter Φ21 of the protrusion 16z at the portion where the outer diameter of the protrusion 16z is the largest is larger than the outer diameter Φ3 of the inner envelope 53 of the first resin layer 50C. In the guide wire 1z of such a comparative example, there is a possibility that the protrusion 16z may get caught on the device used in combination. In other words, in the guide wire 1z of the comparative example, there is room for improvement in slidability with respect to the combined device. Therefore, as described in the fourth embodiment, the outer diameter Φ2 of the protrusion 16 is preferably smaller than the outer diameter Φ3 of the inner envelope 53 of the first resin layer 50C.

<Fifth embodiment>
FIG. 12 is an explanatory diagram illustrating the configuration of the guide wire 1D of the fifth embodiment. The guide wire 1D of the fifth embodiment includes a first resin layer 50D instead of the first resin layer 50 in the configuration described in the first embodiment. The first resin layer 50D can be formed from a resin material that is the same as the second resin layer 30 or has a lower hardness than the second resin layer 30, for example, soft urethane. In this way, the configuration of the guide wire 1D can be modified in various ways, and the first resin layer 50D and the second resin layer 30 may be formed of the same material. The guide wire 1D of the fifth embodiment can also provide the same effects as the first embodiment.

<Sixth embodiment>
FIG. 13 is an explanatory diagram illustrating the configuration of a guide wire 1E according to the sixth embodiment. The guide wire 1E of the sixth embodiment includes a second resin layer 30E instead of the second resin layer 30 in the configuration described in the first embodiment. The second resin layer 30E has a proximal end 30p located at substantially the same location as the proximal end 50p of the first resin layer 50. That is, the second resin layer 30E covers the entire outside (outer peripheral surface) of the first resin layer 50 (the recessed portion 51 and the thinned portion 52). In this way, the configuration of the guide wire 1E can be modified in various ways, and the proximal end 30p of the second resin layer 30E is approximately the same as the proximal end 50p of the first resin layer 50. It may be arranged at the same location or closer to the proximal side than the end 50p of the first resin layer 50 on the proximal side. The guide wire 1E of the sixth embodiment can also provide the same effects as the first embodiment.

<Seventh embodiment>
FIG. 14 is an explanatory diagram illustrating the configuration of the guide wire 1F of the seventh embodiment. The guide wire 1F of the seventh embodiment includes a first resin layer 50F instead of the first resin layer 50 in the configuration described in the first embodiment. The first resin layer 50F does not include the thin portion 52 described in the first embodiment. In this way, the configuration of the guide wire 1F can be modified in various ways, and the first resin layer 50F without the thin portion 52 may be used. Further, the corner portion (FIG. 14: dashed circle frame) on the base end side of the first resin layer 50F may be rounded at an arbitrary angle. The guide wire 1F of the seventh embodiment can also provide the same effects as the first embodiment.

<Eighth embodiment>
FIG. 15 is an explanatory diagram illustrating the configuration of a guide wire 1G according to the eighth embodiment. The guide wire 1G of the eighth embodiment has the configuration described in the fourth embodiment, but includes a core wire 10G instead of the core wire 10C. The core wire 10G includes a protrusion 16G instead of the protrusion 16. In the protruding portion 16G, the reduced diameter portion 161 and the enlarged diameter portion 162 are rounded and loosely connected. In other words, the protrusion 16G has a substantially semicircular shape in the illustrated cross section. The guide wire 1G of the eighth embodiment can also provide the same effects as those of the first to fourth embodiments.

<Modification of this embodiment>
The present invention is not limited to the above-described embodiments, and can be implemented in various forms without departing from the spirit thereof. For example, the following modifications are also possible.

[Modification 1]
In the first to eighth embodiments described above, an example of the configuration of the guide wires 1, 1A to 1G was shown. However, the configuration of the guide wire 1 can be modified in various ways. For example, the guide wire 1 does not need to have the narrow diameter portion 11 and the first reduced diameter portion 12. For example, the core wire 10 of the guidewire 1 may be formed from a plurality of core wires formed using different materials. For example, the second resin layer 30 does not need to cover the tip joint portion 40 or the entire coil body 20. For example, the first resin layer 50 may be configured integrally with the second resin layer 30. For example, the proximal end portion 50p of the first resin layer 50 may be provided in contact with the second reduced diameter portion 14 of the core wire 10.

[Modification 2]
The configurations of the guide wires 1, 1A to 1G of the first to eighth embodiments and the configurations of the guide wires 1, 1A to 1G of the first modification may be combined as appropriate. For example, in the configuration of the first embodiment, the inner envelope portion 53 (third embodiment) may be provided, or the protrusion portion 16 (fourth and eighth embodiments) may be provided. For example, in the configurations described in the second, third, and fourth embodiments, the first resin layer 50D of the fifth embodiment may be used, or the second resin layer 30E of the sixth embodiment may be used. Alternatively, the first resin layer 50F of the seventh embodiment may be used.

Although the present aspect has been described above based on the embodiments and modified examples, the embodiments of the above-described aspect are for facilitating understanding of the present aspect, and do not limit the present aspect. This aspect may be modified and improved without departing from the spirit and scope of the claims, and this aspect includes equivalents thereof. Furthermore, if the technical feature is not described as essential in this specification, it can be deleted as appropriate.

1, 1A to 1G, 1w to 1z... Guide wire 10, 10C, 10G... Core wire 11... Small diameter part 12... First reduced diameter part 13... First large diameter part 14... Second reduced diameter part 15... Second thick part Diameter portion 16, 16G, 16w, 16z... Projection portion 20... Coil body 21... Wire 30, 30B, 30E... Second resin layer 31... Recessed portion 40... Tip joint portion 50, 50B to 50D, 50F, 50x, 50y... First resin layer 51... Biting part 52, 52C, 52w... Thin wall part 53... Inner envelope part 60... Intermediate fixing part 70... Regulating part 161... Diameter reduction part 162... Expansion diameter part

Claims (8)

A guide wire,
core wire and
a first resin layer covering a portion of the core wire;
another part of the core wire, a coil body wound around the outside of the first resin layer,
a second resin layer covering the coil body;
A portion of the coil body is embedded in the first resin layer and the second resin layer,
The guide wire includes: an indirect bonding portion where the first resin layer and the second resin layer are bonded via the coil body at contact surfaces where the first resin layer and the second resin layer respectively contact the coil body; The first resin layer and the second resin layer have a direct bonding portion that is a portion directly bonded at a contact surface between the first resin layer and the second resin layer. , guidewire. The guide wire according to claim 1,
In the guide wire, the second resin layer has a lower hardness than the first resin layer. The guide wire according to claim 1 or claim 2,
The guide wire, wherein the proximal end of the first resin layer is located closer to the proximal end of the core wire than the proximal end of the second resin layer. The guide wire according to any one of claims 1 to 3,
In the guide wire, the proximal end of the first resin layer becomes thinner toward the proximal end of the core wire. The guide wire according to any one of claims 1 to 4,
The first resin layer has, on the proximal end side, an inner envelope portion in which the entire proximal end portion of the coil body is embedded in the first resin layer;
The guide wire, wherein the second resin layer is disposed only on the distal side from the distal end of the internal capsule part. The guide wire according to any one of claims 1 to 5,
The core wire is a guide wire, and the core wire has a protrusion with an enlarged diameter at a position in contact with a proximal end of the first resin layer. The guide wire according to claim 6,
The protrusion has a reduced diameter portion whose outer diameter decreases from the proximal end side to the distal end side,
In the guide wire, a proximal end portion of the first resin layer is provided in contact with the reduced diameter portion. The guidewire according to any one of claims 1 to 7, further comprising:
A guide wire, comprising: a regulating portion provided between the coil body and the core wire on the distal side of the first resin layer, and in which another part of the coil body is embedded.

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